Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT05448651
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged 18 to 60, and has physician-diagnosed asthma
2. Body mass index (BMI) between 18 and 35 kg/m2
3. Blood eosinophil cell count ≥200 (OR ≥150 combined with fractional exhaled nitric oxide \[a measure of lung airway inflammation\] \>25) at one screening visit and ≥150 at the other screening
4. Agrees to follow the required contraceptive techniques
5. Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug
6. Able to perform spirometry (breathing tests)
7. Asthma and non-biologic asthma medication have been stable for the past 2 months
Exclusion Criteria:
1. Employee, consultant, and/or immediate family member of any person involved in the conduct of the study
2. Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients
3. Pregnant or breastfeeding female
4. Unable to fast and avoid strenuous exercise for 9 hours prior to each site visit
5. Serious allergic reaction to any injected drug
6. Significantly abnormal clinical laboratory test results or a significant medical condition
7. Recently donated blood (including blood products) or experienced significant loss of blood
8. Has pacemaker or a significantly abnormal electrocardiogram
9. An active or a serious infection in the past 8 weeks
10. Poorly-controlled diabetes or abnormal kidney function
11. Tests positive to illicit drugs or nicotine and cannot limit alcohol consumption
12. Tests positive for human immunodeficiency virus antibodies (HIV), hepatitis B, hepatitis C antibodies, or tuberculosis
13. Received any vaccine within the past month
14. Received any immunosuppressant therapies in the past
15. Received an antibody or therapeutic biologic product in the last 6 months
16. Received steroids (other than inhaled) in the past 2 months
17. Participated recently in a clinical study
18. Current tobacco smokers or has smoked within the last year
19. Tested positive for COVID-19 in the past month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05448651
Study Brief:
Protocol Section:
NCT05448651